Kornimate/medical-research-clean huggingface dataset:
sparing of organs at risk in high dose rate brachytherapy

Conditions: Cervical Carcinoma Stage IB to IV

Summary: cervix carcinoma is a common malignancy. radiation therapy still remains a major treatment for patients with carcinoma cervix. conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. low dose rate intracavitary brachytherapy treatment is already well studied. but high dose rate brachytherapy is a relatively new alternative. in brachytherapy, major developments have been made in the integration of 3d imaging and computerized 3d treatment planning. medical imaging improvements allowed for better definition of tumoral volumes and organs at risk. the gyn gec-estro published recommendations on the 3d imaging for better characterization of these volumes. improvements in ct-scan and lately in rmn had lead to a better definition of volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis, small bowels). rmn is the imaging standard in the evaluation of tumoral extension in cervix cancer. however its use is not easy in many brachytherapy departments. this study will evaluate the feasibility and sparing of organs at risk for high dose rate brachytherapy if volume delineation is done at each of the two sessions performed with 3d rmn.

after 60 gy are delivered with intensity modulated radiation therapy (imrt), the brachytherapy in high dose rate will deliver 15 gy to the ctvhr (high risk ctv) in two sessions. a clinical examination and an rmn are performed at the end of the external radiation to evaluate the residual tumoral volume. two hdr brachytherapy sessions are then performed. during the first session, a ct-scan and an rmn will be performed after the fletcher application. a second ct-scan will be performed during the second treatment session to create new volumes and to improve organs at risk sparing.

Eligibility criteria:
inclusion criteria: * cervix carcinoma stage ib to iv (figo) * oms \< 2 * tomography by positron emission and/or chirurgical staging before the external radiotherapy * rmn before the starting of treatment and at the end af external radiotherapy * patient information * validation of the indication af high dose rate brachytherapy * external radiation therapy (60 gy with imrt) exclusion criteria: * no external radiation therapy * surgery in the 4 weeks before before the inclusion * prior pelvic radiation therapy * intestinal inflammatory disease or active pathology * active infection or severe pathology didn't allow the treatment * prior carcinoma in the last 5 years (except cutaneous carcinoma or in situ carcinoma) * inclusion in another clinical trial

Keywords: stade ib to iv cervix cancer ambulatory high dose rate brachytherapy
sarcoid genetic analysis (saga)

Conditions: Lung Diseases; Sarcoidosis

Summary: to identify sarcoidosis susceptibility genes and to determine how these genes and environmental risk factors interact to cause sarcoidosis.

background: sarcoidosis is a rare systemic granulomatous disease that mainly affects young to middle aged adults, and more severely affects african americans than caucasians. the etiology of sarcoidosis is not yet known, and epidemiological studies have only identified general risk factors including age, sex, race, and family history. sarcoidosis may also be influenced by environmental factors, although the particular environmental agents have not yet been clearly defined. while previous studies have provided evidence for familial clustering, little is known about the genes that influence predisposition to sarcoidosis. design narrative: this is a multicenter consortium genetic epidemiology study. the investigators will accomplish their goal by organizing a 10-site multi-center consortium to recruit an adequate sample of sarcoidosis families for analysis. they plan to use the affected sibling pair linkage analysis to scan the genome for linked chromosomal regions, transmission disequilibrium testing to evaluate candidate genes in those regions with evidence for linkage, and an environmental questionnaire to collect data to test for possible interactions of susceptibility genes with exogenous risk factors. genotyping and analysis of data are scheduled to begin in july, 2001 with completion of all analysis by april, 2004. the study consists of a clinical core, a data coordinating core, and a genetics core with a dna processing center and a genotyping center. eight of the ten clinical centers comprising the clinical core are members of the access, a case control etiology of sarcoidosis study. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
effect of exercise on metabolic health

Conditions: Obesity

Summary: one of the main objectives of this study will be to assess potential differences in important risk factors associated with metabolic syndrome in overweight adults who do not participate in a regular exercise program compared with overweight individuals who do exercise regularly. in addition, we will determine the effects of a single, modest session of exercise on the body's ability to control blood sugar and regulate fat metabolism in obese sedentary adults vs. obese adults who live a physically active lifestyle. our study focuses on identifying mechanisms responsible for improved insulin action related to regular exercise and to provide novel targets for preventing and treating type 2 diabetes.


Eligibility criteria:
inclusion criteria: * body mass index \[bmi\] = 30-45 kg/m2, fasting blood glucose concentration must be \ or = to 34%, all women must be pre-menopausal exclusion criteria: * pregnancy or actively breastfeeding, weight instability (\> or = to ± 5 lbs in the past month) evidence of cardiovascular or metabolic diseases, taking medications know to affect lipid and/or glucose metabolism.

Keywords: insulin sensitivity exercise metabolism
study of nivolumab in unresectable advanced or recurrent esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of study is to evaluate the efficacy and safety of nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.


Eligibility criteria:
inclusion criteria: * men \& women ≥20 years of age * histologically confirmed unresectable advanced or recurrent esophageal cancer * refractory to or intolerant of standard therapy * ecog performance status score 0 or 1 * a life expectancy of at least 3 months exclusion criteria: * current or past history of severe hypersensitivity to any other antibody products * patients with multiple primary cancers * patients with any metastasis in the brain or meninx that is symptomatic or requires treatment * patients with active, known or suspected autoimmune disease
the tricure efs study

Conditions: Tricuspid Valve Regurgitation; Heart Valve Diseases; Cardiovascular Diseases

Summary: prospective, multi-center study to assess safety and performance of the tricares topaz tricuspid valve replacement system

the study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the tricares topaz tricuspid valve replacement system.

Eligibility criteria:
inclusion criteria: * adult patients * tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential) * institutional heart team evaluates patient as being at increased operative risk exclusion criteria: * patient in need of emergent intervention * patient who is hemodynamically unstable * anatomical contraindications for implantation with study device * patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
exercise and emotional learning in posttraumatic stress disorder

Conditions: PTSD

Summary: the goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of ptsd. participants will complete a baseline intake followed by two experimental sessions. during the first experimental session, participants will undergo an mri session of imaginal exposure to traumatic memory cues followed by 30-minutes of moderate intensity exercise or low intensity exercise. participants will complete a second session of imaginal exposure with mri 24 hours later.

the proposed project would build on our published pilot data and animal models to demonstrate that moderate intensity physical exercise delivered after exposure therapy engages fear circuitry and enhances the consolidation of therapeutic safety learning, thereby enabling enhanced symptom reduction for ptsd. adults with ptsd related to interpersonal violence (ipv) exposure would complete an initial session of imaginal exposure to traumatic memory cues adapted for an mri setting. this would be followed by 30-mins of moderate intensity exercise or low intensity exercise control. participants would return 24-hrs later to complete a second session of imaginal exposure with mri.

Eligibility criteria:
inclusion criteria: * adults with ptsd related to interpersonal violence exclusion criteria: * active or recent (within the last 3 months) severe substance use disorder(s) * active or recent (within the last 3 months) suicidal, psychotic, or manic symptoms/ episodes * significant developmental disabilities * current daily benzodiazepine or stimulant use with inability to abstain for study sessions * recent changes in psychiatric medication or trauma focused cognitive-behavioral therapy (cbt) (past 4-weeks) * medical condition(s) that prohibit exercise * history of traumatic brain injury (tbi) with loss of consciousness \> 30 mins * magnetic resonance imaging (mri) contraindication(s) * positive pregnancy test * history of seizure disorder * spontaneous seizure(s) within the last 3 months

Keywords: interpersonal violence exercise
evaluation of diaphragm movement after an interscalene block

Conditions: Phrenic Nerve Paralysis

Summary: the purpose of this study is to evaluate the movement of the diaphragm after an interscalene block with liposome bupivacaine (lb) compared to interscalene block (ib) with bupivacaine. this study will evaluate if there is a possible prolonged phrenic nerve paralysis when using liposome bupivacaine in an interscalene block, using ultrasound.

this study will be run concurrently with two other studies comparing bupivacaine to liposomal bupivacaine in shoulder surgeries. we will use already randomized patients for our randomization process. for this study in particular we will use an ultrasound machine to scan the diaphragm of any patient who had an interscalene block for total shoulder arthroplasy or rotator cuff repair. patients are to be scanned in an upright sitting position and scanned from a low intercostal or subcostal approach using the liver or spleen as an acoustic window. m mode will be applied and the range of diaphragmatic movement from the resting expiratory position to deep inspiration (sigh test) will be recorded as was the range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test). the blocks will be done regardless of the study as they are standard of care for pain control. the only intervention is ultrasound examination of the patient's diaphragm at baseline, 3 hours post block in recovery room and on post-operative day 1, and basic spirometry to record fev1 and fvc via a portable spirometer at the same time points. if patients did stay in hospital on postoperative day 2 we would also evaluate their diaphragm function.

Eligibility criteria:
inclusion criteria: * all patients age 18 years and older who are scheduled for shoulder surgery with interscalene block and remain in the hospital for more than 24 hours that are being randomized into a bupivacaine versus liposomal bupivacaine interscalene block study. exclusion criteria: * non english speaking patients.
study to assess the efficacy and safety of a parp inhibitor for the treatment of brca-positive advanced ovarian cancer

Conditions: Ovarian Neoplasm

Summary: the purpose of the study is to see if the drug ku 0059436 is effective and well tolerated in treating patients with measurable brca1- or brca2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.


Eligibility criteria:
inclusion criteria: * advanced ovarian cancer with positive brca1 or brca2 status * failed at least one prior chemotherapy * in investigators opinion, no curative standard therapy exists * measurable disease exclusion criteria: * brain metastases * less than 28 days since last treatment used to treat the disease * considered a poor medical risk due to a serious uncontrolled disorder

Keywords: advanced ovarian cancer poly(adp ribose) polymerases ku-0059436 azd2281 brca1 protein brca2 protein
patellofemoral pain after unicondylar knee arthroplasty

Conditions: Mobile-bearing Unicondylar Knee Arthroplasty

Summary: unicondylar knee arthroplasty (uka) is a proven procedure in patients suffering from unicompartmental knee osteoarthritis. two different types of uka design are available - both with different pros and cons. the so-called 'mobile-bearing uka' requires the removal of an additional amount of cartilage and bone close to the implantat. it is unclear whether this is of clinical relevance. we speculate that the amount of cartilage/bone removal is related to the clinical outcome of the uka-surgery. in patients receiving a mobile-bearing uka that amount of cartilage/bone removal is measured during the surgery. the clinical success of the procedure will be determined with certain knee questionnaires (kujala \& koos)preoperatively, 3 months postoperatively, 6 months postoperatively and 1 year postoperatively. additionally, the so-called bone-remodelling around that area of resected cartilage and bone will be measured (spect-ct) postoperatively. the three variables (removed amount of cartilage/bone; clinical success with regard to the questionnaires; bone remodelling) are then analyzed with statistical methods to find out potential assoziations among them.


Eligibility criteria:
inclusion criteria: - osteoarthritis or osteonecrosis in the medial or lateral tibiofemoral compartment exclusion criteria: * failed upper tibial osteotomy * insufficiency of the collateral or anterior cruciate ligaments * a fixed varus or valgus deformity (not passively correctable) above 15° * a flexion deformity greater than 15° * rheumatoid arthritis

Keywords: unicondylar knee arthroplasty mobile-bearing patellofemoral pain
validation of a predictive rule for the diagnosis of viral meningitis in adult emergency departments

Conditions: Meningitis

Summary: meningitis is the development of an inflammatory reaction in the meningeal space, most often of infectious origin. many pathogens can cause meningitis, the severity of which varies greatly. patients presenting with a febrile meningeal syndrome are most often managed in the emergency room, where the challenge for physicians is to quickly differentiate bacterial and viral meningitis. viral meningitis is the most common, with enterovirus meningitis having a classically excellent prognosis. bacterial meningitis is less frequent but more serious.the current public health objective is to save antibiotics. investigator hypothesizes that the bms score can be used to exclude bacterial meningitis in the emergency department in an adult european population of patients with suspected bacterial meningitis.


Eligibility criteria:
inclusion criteria: * patient admitted to the adult emergency department of ch le mans,chu angers, chu nantes or beaujon hospital. * over 18 years old * having had a lumbar puncture during their stay in the adult emergency department * having had a diagnosis of meningitis defined as a pleocytosis ≥ 5leukocytes/mm3 after correction with csf red blood cells at a standardized ratio of 500/1. exclusion criteria: * antibiotic therapy within 72 hours of inclusion * immunosuppression from any cause * presence of petechiae or purpura * history of recent neurosurgery or head trauma * other associated bacterial infection * inability to collect information for the bms score calculation or primary endpoint (e.g., transfer to another facility) * minor or adult patient under guardianship or protection

Keywords: bms score meningitis
vanderbilt icu recovery program pilot trial

Conditions: Intensive Care Unit Syndrome; Intensive Care Neurological Disorder; Intensive Care (ICU) Myopathy; Intensive Care Psychiatric Disorder (Diagnosis)

Summary: every year, millions of americans are admitted to the intensive care unit. due to advances in critical care, mortality rates are decreasing, increasing the number of icu survivors. survivors of critical illness, however, often face physical, functional, and cognitive deficits that place them at risk for a cycle of re-hospitalization that frequently culminates in premature death. moreover, post-icu interventions may be resource-intensive and may be most cost-effective only in a subgroup of patients at highest risk. whether a multi-disciplinary program to facilitate recovery from critical illness can prevent hospital readmission and improve quality of life among high-risk icu survivors remains unknown. the primary aim of this pilot is to examine the feasibility of implementing a multidisciplinary icu recovery program and the influence of such a program on process measures including contact with the icu recovery team and attendance of icu recovery clinic. the secondary aims are to compare the effect of an icu recovery program on 30-day same-hospital readmission and other clinical outcomes.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. admitted to the medical intensive care unit (micu) at vanderbilt university medical center for at least 48 hours 3. estimated risk of 30-day same-hospital readmission greater than 15% 4. not previously enrolled in the study. exclusion criteria: 1. long-term residence at a skilled nursing facility 2. long-term mechanical ventilation prior to admission 3. solid organ or stem cell transplantation 4. recorded primary residency \> 200 miles from vanderbilt 5. comfort care only
effect of metadoxine on oxidative stress in non-alcoholic hepatic steatosis

Conditions: NAFLD; Pre-diabetes

Summary: oxidative stress is produced by imbalance between reactive oxygen species and antioxidant systems. this state is frequently associated with chronic diseases like obesity, insulin resistance, metabolic syndrome and hepatic steatosis. in the liver, the oxidative stress may trigger the progression of fatty liver disease, from triglyceride accumulation to inflammation, cirrhosis and hepatocellular carcinoma. thus, the attenuation of oxidative stress, could be an important therapeutic target to lessen the severity of the disease. until now, there is not a medical treatment to cure non-alcoholic fatty liver disease, but therapies aimed at reducing oxidative stress have been proposed. metadoxine, an ionic complex of pyridoxine-pyrrolidone molecule, acts as a synthetic antioxidant, forming traps that can reduce free radicals; likewise, metadoxine has a proven capacity to reduce fat liver in alcoholic hepatitis. finally, in fact that alcoholic and non-alcoholic liver diseases share molecular mechanisms in the generation of oxidative stress, the investigators propose metadoxine as a posssible modifier of the oxidative stress in non-alcoholic liver disease, prediabetic patients.


Eligibility criteria:
inclusion criteria: * male and female * 18 to 65 years old * ultrasonographic diagnosis of nafld * prediabetes diagnosis exclusion criteria: * alcoholism * hepatitis c or b virus infection * pregnancy * autoimmune hepatitis * metformin or metadoxine allergy * parenteral nutrition in the last month * weigh loss greater than 10% in the last month * taking vitamin supplements in the last month

Keywords: nafld oxidative stress malondialdehyde
development of dysplasia in the pelvic pouch in patients with ulcerative colitis (uc) and risk factors

Conditions: Ulcerative Colitis; Dysplasia; Surgery

Summary: the purpose of this study is to study development of dysplasia in the ileal mucosa among patients with ulcerative colitis and who previous have hade risk factors for developing cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen.

objective some of the rare complications reported in patients with an ileal pouch-anal anastomosis (ipaa) after colectomy for chronic ulcerative colitis are dysplasia and carcinoma. the supposed pathway is for the ileal pouch mucosa to go through adaptational changes then to progress through the phases of chronic pouchitis, dysplasia and subsequently to adenocarcinoma. the purpose of this study is to study development of dysplasia in the ileal mucosa among patients with ulcerative colitis and who previous have hade risk factors for developing cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen. methods in a cohort of 680 patients having ipaa with a median follow-up time of 18 years, 75 patients with risk factors for dysplasia were identified. sixty-five patients were eligible for inclusion, fifty-six patients accepted to participate in the study. patients are invited for clinical examination, endoscopy with macroscopic evaluation as well as mucosal biopsies. the biopsies are reviewed and evaluated by two independent pathologists, experienced in colonic pathology, concerning morphological changes, dysplasia and potential carcinoma results architectural structural changes, inflammation and reactive atypia is noted in the rectal cuff and ileal pouch. so far, none of the biopsies showed genuine dysplasia after a follow up for 18 years (range 12-23 years). in this respect there is full agreement between the two pathologists. further microscopic evaluation are planned for the rest of the participating patients.

Eligibility criteria:
inclusion criteria: * uc (ulcerative colitis) * ipaa * risk factor for dysplasia exclusion criteria: * not able to give consent * cd (crohns disease)

Keywords: ulcerative colitis dysplasia risk factor surgery